Billing and Coding: MolDX: Targeted and Comprehensive Genomic Profile Testing in Cancer

This policy defines when to bill and code tumor-based targeted NGS panels and comprehensive genomic profile (CGP) testing for cancer. Targeted panels (hotspot-focused DNA or RNA tests) should be billed with specified CPT codes (e.g., 81445/81450; 81449/81451 for RNA) when clinically indicated, while CGPs that meet defined components and technical assessment requirements may be billed with CPT 81459 (or 81479 when 81459 criteria are not met); all NGS panel claims must include the approved DEX Z-Code and the unit of service reported as one. Coverage of a CGP is limited to one test per surgical specimen and use of single-gene Tier 1/2 CPT codes is prohibited when genes are tested as part of an NGS/multiplex panel.

"Targeted tumor panels are covered when the test identifies somatic alterations in defined hotspot regions known to affect cancer management (diagnosis, selection of molecularly targeted therapies, ..."